BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7364559 · Received March 22, 2018

    Report

    Report Number
    1213809-2018-00195
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    March 12, 2018
    Report Date
    April 19, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052692
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SAMPLES FROM THREE LOTS WERE RETURNED FOR ANALYSIS. D.4. DEVICE LOT #: 7001876. D.4. DEVICE EXPIRATION DATE: 12/31/2021. H.4. DEVICE MANUFACTURE DATE :01/01/2017. D.4. DEVICE LOT #: 6201981. D.4. DEVICE EXPIRATION DATE: 12/31/2021. H.4. DEVICE MANUFACTURE DATE : 01/01/2017. D.4. DEVICE LOT #: 6004730. D.4. DEVICE EXPIRATION DATE: 12/31/2021. H.4. DEVICE MANUFACTURE DATE : 01/04/2016. H.6. INVESTIGATION RESULTS: SAMPLE EVALUATION: ONE SHELF CARTON RECEIVED BY BD CANAAN CONTAINING MULTIPLE PACKAGED INTEGRA SYRINGES WITH NEEDLE. SEE BELOW FOR DETAILS. 87 SEALED AND 1 OPEN PACKAGED SYRINGES CONFIRMED TO BE FROM BATCH # 7001876 (P/N 305269) ONE SAMPLE BAG CONTAINING 20 SEALED AND 2 OPEN PACKAGED SYRINGES CONFIRMED TO BE FROM BATCH # 6201981 (P/N 305269). THE SAMPLE BAG ALSO CONTAINED ONE OPEN PACKAGED SYRINGE CONFIRMED TO BE FROM BATCH #6004730 (P/N 305269) . THE SAMPLES WERE VISUALLY EVALUATED. 20 SYRINGES WERE RANDOMLY SELECTED TO PERFORM VISUAL EVALUATION OF ASSEMBLED SYRINGES. NO VISUAL DEFECTS WERE OBSERVED. THE DROPLETS OBSERVED INSIDE THE SYRINGES IS SILICONE USED IN THE MANUFACTURING PROCESS. THE SMALL AMOUNT OBSERVED IS NORMAL AND EXPECTED AMOUNT FOR THIS PRODUCT PER PRODUCT SPECIFICATION. DHR REVIEW FOR BATCH 7001876 (P/N 305269): MANUFACTURING DATES: 01/27/2017 TO 01/29/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7001876 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 6201981 (P/N 305269): MANUFACTURING DATES: 08/14/2016 TO 08/23/2016. BATCH QUANTITY WAS (B)(4).VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6201981 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 6004730 (P/N 305269): MANUFACTURING DATE: 01/09/2016 TO 01/18/2016. BATCH QUANTITY WAS (B)(4) ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6004730 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. PLEASE NOTE THAT SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. BASED ON THE SAMPLE EVALUATION: UNCONFIRMED: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE AND CAPA NOT REQUIRED AS NO DEFECTS WERE CONFIRMED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE FELT SLIPPERY BEFORE USE. CUSTOMER NOTED THEY COULD SEE DROPLETS INSIDE THE SYRINGE. NO REPORTS OF SERIOUS INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204146 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 7001876 30382903052692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other